FOXBORO, MA and CORK, IRE - Deploying an MES system or MES individual objects into a production environment has many benefits but , as with any other complex software, there are risks associated with it. However, MES cannot be viewed in the same way as other technology-based system implementations. MES drastically changes the business process in the same way that operations used to, and as such, has a major impact on the daily business life of end users.

Successful deployment of an MES system depends strongly on obtaining input from every department that is affected by its introduction, as well as on successful change management, which is a major component of technology, people, and business process alignment.

The following is a list of 10 key considerations to keep in mind when developing a strategy and plan for the deployment of MES objects into production.

1. Roles

Roles and responsibilities within the deployment team and related departments need to be clearly defined from the outset.

2. Sequence

Establishing a logical deployment sequence based on current plant processes is key. This depends on how the system interconnects the individual steps within a process. It is particularly important when deploying recipes to use in production for the first time.

A logical deployment sequence should be identified at the beginning of the project and reviewed throughout the project up to the deployment phase. Process diagrams are a key reference when establishing a logical sequence for deployment.

3. Integration between MES and other systems within the site

It is important to coordinate availability of integrated systems for deployment scheduling purposes. Risks of integration should be defined so that appropriate actions are taken in case of failure or other circumstances.

4. Change management and training

Involving end users throughout the project stages helps them familiarize with the MES capabilities and to embrace it. SOPs and other training resources should be developed early on to get end users prepared for the deployment and subsequent use of the system. In addition, an experienced individual, who is able to develop and lead a change management programme that is concurrent with the other project tasks, should be assigned. This will help to ease any business culture change issues. Training planning should be handled as part of this change management strategy.

5. Early identification of resource and equipment needs

Identify and communicate resources and equipment needs to all appropriate personnel (including HR) in good time. Get their input about time they need to allocate resources and prepare equipment, and try to manage your schedule around it. Take into consideration that, in many cases, the site is still in full production and resources are not always available.

6. A well-defined installation and decommissioning strategy

In order to maintain consistency in the installation process, the installation steps need to be defined, documented, understood, and followed by every person involved in the installation process. Defining decommissioning steps is critical in case of failure or unexpected circumstances during deployment.

7. Creation and use of deployment checklists

Deployment checklists are useful to verify and keep track of software objects names and version, qualification status, person responsible, date of deployment, and any other relevant information for tracking purposes.

8. Testing methods

Identify how the system will be tested before deployment (test environment) and after deployment (production environment), especially integration testing. Make sure to involve end users in the production test. Input from end users is particularly valuable during testing, due to their knowledge of how the process works and issues they have experienced in the past.

9. Qualification

Prepare a validation strategy and plan that includes equipment verification protocols, MES core system verification, recipe execution, and integration qualification. You should also engage a regulatory compliance process to include risk assessment and risk based qualification for the project efficiency and quality.

System Development Life Cycle (SDLC) methodology can be utilized for qualification and documentation throughout the system life cycle. Utilization of vendor QMS process following a vendor qualification audit can save a significant time and money for the MES deployment.

10. Communication

Keep everybody informed during the deployment process by holding regular progress meetings involving effected personnel. It is a good idea to document input from end users that might help improve the system or address concerns. Implement an effective issue escalation and resolution process between the vendor, project team, and other key stakeholders.

About Enterprise System Partners (ESP):

Enterprise System Partners (ESP) is a leading global consulting and project engineering company - supporting system implementations for the life science industry since 2003.

We offer specialist support and consulting services exclusively for manufacturing operations in biotechnology, pharmaceutical and medical devices, with core focus on Manufacturing Execution Systems (MES) and serialization.

Our specialist consultants and engineers have the expertize to support the concept, planning, vendor selection, design and implementation of the entire manufacturing systems landscape from process automation to the enterprise layer (level 0-4).

We have offices in Cork, Dublin, Boston and San Francisco allowing us to support projects with local resources worldwide.